Running head: REDUCING HAPIs 1

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Running head: REDUCING HAPIs 1 Reducing Hospital-Acquired Pressure Injuries through the implementation of the Leaf Patient Monitoring System Meghan Kelley Jacksonville University DNP Chair: Ashlee Loewen, DNP, APRN, FNP-C Additional Team Member: Peter Wludyka, PhD

Transcript of Running head: REDUCING HAPIs 1

Page 1: Running head: REDUCING HAPIs 1

Running head: REDUCING HAPIs 1

Reducing Hospital-Acquired Pressure Injuries

through the implementation of the Leaf Patient Monitoring System

Meghan Kelley

Jacksonville University

DNP Chair: Ashlee Loewen, DNP, APRN, FNP-C

Additional Team Member: Peter Wludyka, PhD

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A DNP PROJECT

Reducing Hospital-Acquired Pressure Injuries

through the implementation of the Leaf Patient Monitoring System

A Project Presented to the Faculty of Keigwin School of Nursing

Jacksonville University

In partial fulfillment of the requirements

For the Degree of Doctor of Nursing Practice

by

Meghan Kelley

Approved: Ashlee Loewen, DNP, APRN, FNP-C

DNP Chair

Approved: Lila de Tantillo, PhD, MS, FNP-BC

DNP Secondary Advisor and Reader

Approved: Lindsay Wolf, DNP, APRN, CPNP-PC, CNE, CLC

Graduate Director for DNP Program, Keigwin School of Nursing

Approved: Leigh Hart, PhD, APRN-BC

Associate Dean, Keigwin School of Nursing

Date: April 29, 2021

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Table of Contents

Introduction 5

Nursing-Sensitive Implications 5

Financial Implications 7

Significance 7

Purpose 9

Framework 10

Theoretical Framework 10

Quality Improvement Model 12

Definition of Terms 12

Review of Literature 13

Risk Assessment 14

Turn Period 16

Multicomponent Interventions 18

Patient Monitoring Technology 20

Synthesis of Findings 26

Project Description 27

Outcomes 27

Intervention 28

Technology 28

Plan 29

Key Stakeholders 29

Setting and Population 30

Education 31

Fiscal Consideration 33

Confidentiality 33

Institutional Review Board Plan 34

Do 34

Measures 35

Study 36

Evaluation Plan 36

Act 37

Sustainability 37

Timeline 37

Findings 39

Objectives Met 39

Objectives Not Met 40

Data Analysis 40

HAPI Data Analysis 40

Turning Compliance Data Analysis 41

Facilitators and Positive Outcomes 41

Barriers and Negative Outcomes 42

Adverse Events 44

Recommendations 44

Discussion 45

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References 47

Appendix A 52

Appendix B 53

Appendix C 54

Appendix D 55

Appendix E 72

Appendix F 74

Appendix G 75

Appendix H 76

Appendix I 77

Appendix J 78

Appendix K 79

Appendix L 80

Appendix M 81

Appendix N 82

Appendix O 84

Appendix P 85

Appendix Q 86

Appendix R 87

Appendix S 88

Appendix T 89

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Reducing Hospital-Acquired Pressure Injuries through the implementation of the Leaf Patient

Monitoring System

Introduction

A top priority for all hospitals is patient safety, defined by the World Health Organization

(WHO) as an absence of preventable harm and the reduction of risk of unnecessary harm to a

patient throughout a hospitalization (WHO, 2020). A major component of patient safety

classified under this category is prevention of hospital-acquired pressure injuries (HAPIs), which

are considered “never-events” by the Joint Commission and align with the WHO as preventable

harm. Pressure injuries (PIs) are a National Database of Nursing Quality Indicator (NDNQI)

nursing-sensitive indicator (WHO, 2020). HAPIs can affect the overall hospital quality star

rating, which is an important measure of all hospitals open to the public. These star ratings can

either influence the reputation of the institution among the general population and the Magnet

status of an institution.

This quality improvement (QI) initiative addressed the high occurrence rate of HAPIs on

a particular unit in a hospital with Magnet status designation. The intent of this QI project was to

reduce HAPIs and improve patient outcomes through a technology-focused intervention.

Nursing-Sensitive Implications

HAPIs have been a nursing quality measure since the beginning of nursing, as evidenced

by Florence Nightingale’s text in Notes on Nursing published in 1859, “if he has a bedsore, it’s

generally not the fault of the disease, but of the nursing” (Nightingale, 1859). Since this time,

HAPIs have been a main focus of patient outcomes that can be directly related to nursing quality.

This is due to the fact that the majority of the preventative care for HAPIs is within the nursing

scope of practice. This includes topics such as having risk assessments documented, use of skin

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care products and the management of excessive moisture that can contribute to skin breakdown,

the mechanisms used to reposition and the frequency of the repositioning that occurs, and the

type of bed surface the patient is placed on all contribute to the development or prevention of

HAPIs (Lyder & Ayello, 2008). Due to these nursing responsibilities that play a large role in

HAPI prevalence, governing bodies of quality, such as NDNQI and The Magnet Program, use

occurrence rates of HAPIs to determine ratings and status of institutions, specifically related to

nursing.

The NDNQI is a national nursing quality measurement program that provides hospitals

with unit-level performance in comparison to state and national results (Agency for Healthcare

Research and Quality, 2014). Data is collected every three months on many different nursing

topics, such as falls, nosocomial infections, and pressure injuries, providing a clear

representation of nursing quality and the connectedness of nursing interventions with patient

outcomes. The results provide valuable evidence to support change, such as QI initiatives, as

well as provide data to accrediting organizations such as the Joint Commission and the Magnet

Recognition Program.

The Magnet Recognition Program, which includes the NDNQI measures, is awarded to

an organization that has an alignment of nursing leaders and nursing strategic goals to improve

the patient outcomes (American Nurses Credentialing Center, 2020). When an organization

becomes Magnet, nurses are empowered to reach their true potential, and the organization

demonstrates its ability to lead in healthcare change. Mayo Clinic Florida (MCF), an institution

that has committed to excellence, continues to maintain Magnet status as one of only 20 hospitals

within the state of Florida with this designation. Due to this commitment, innovation, evidenced-

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based research, and QI initiatives must be continually incorporated into practice to maintain

patient safety and top patient outcomes.

Financial Implications

In addition to quality organizations paying close attention, the Centers for Medicare and

Medicaid Services monitor pressure injuries as well (CMS, 2019). In 2008, CMS declared that

reimbursement would no longer be received for the care or treatment of pressure injuries that

develop throughout the hospitalization that are graded stage II or above (this excludes PIs present

on admission), in effect a reimbursement penalty for the organization. The CMS collects this

data from the NDNQI through quarterly pressure injury prevention surveys from hospitals across

the nation. This data then determines the unit-specific 50th percentile reimbursement benchmark

for pressure injuries.

This means if a unit is below the 50th percentile unit-specific national mean, there is no

reimbursement penalty incurred from CMS. The 50th percentile means for reimbursement in the

progressive care unit was 1.61% for the second quarter of 2019. This number was acquired from

quality data within the Mayo Clinic intranet derived from the NDNQI pressure injury prevention

survey data. The number of 1.61% sets the benchmark for CMS reimbursement at the institution,

which means a calculation of less than 1.61% pressure injuries that are a stage II or above within

the unit would meet this benchmark and not receive a financial penalty. Due to these existing

measures, not only are pressure injuries a very important quality indicator of nursing care, but

they can also become a source of financial burden for an organization.

Significance

The information above led to the development of this QI initiative to reduce the HAPI

occurrence rate on the progressive care unit (PCU) at Mayo Clinic in Jacksonville. In 2018, the

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PCU missed the 1.61% benchmark, which is the 50th percentile national mean average, with an

incidence rate of 8.33% of pressure injuries staged II or above. Again in 2019, the pressure

injury incidence rate was 3.85%, still above the NDNQI benchmark rate of 1.61%. The specific

number of PIs was 32 and 12 for the years 2018 and 2019, respectively. Currently, within the

first five months of 2020, there have been six total pressure injuries, trending toward missing the

1.61% benchmark rate again.

The PCU at Mayo Clinic has policies in place to prevent and reduce the occurrence of

HAPIs. These current practice policies include a full skin assessment on admission, or transfer

from another unit within the facility, with the nurse and the charge nurse. The use of the second

nurse during this assessment is to ensure that any wound or injury found on the patient is clearly

documented and relieves the unit of assuming responsibility for the injury. If the patient does

have a pressure injury on admission, the nurse is to inform the provider, place a wound/ostomy

care (WOC) consult, document the finding, and receive consent from the patient to photograph

the area. The WOC nurses will typically see the patient within 24 hours of admission and

provide recommendations, place nursing orders for wound care as needed, and order specialty

mattresses and other equipment as needed.

Secondly, current practice on the PCU requires an integumentary assessment using the

Braden Scale to be documented every shift or every 12 hours. This accounts for any changes in

the patient’s status that could affect the integumentary system. The Braden Scale has proven to

be a reliable tool to assess a patient’s risk for developing a pressure injury (Cox et al., 2018;

Hodl et al., 2019; Padula et al., 2018; Shieh et al., 2018; Yilmazer & Bulut, 2019). It addresses

six categories that the nurse must assess: sensory perception, moisture, activity, mobility,

nutrition, and friction/shear (see Appendix A). The scale gives results from six to 23, with those

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receiving lower numbers being more at risk for developing a PI. Currently, there is no further

action taken by the unit nurse if the result has decreased from the previous shift.

Lastly, it is standard practice on the unit to turn patients every two hours. There is no

formal responsibility between the nurse or patient care technician (PCT) regarding who initiates

this required task. Unfortunately, no data is available to demonstrate nurse or PCT compliance of

the scheduled two-hour turns on the unit. In general, evidence suggests around a 60%

compliance rate with patients being turned by every two by staff within hospitals across the

country (Pickham et al., 2016).

Due to the current policies and practices not proving to be effective at reducing the

incidence of HAPIs on the PCU as evidenced by missing the NDNQI unit-specific national

mean, the implementation of the FDA-cleared Leaf Patient Monitoring System was proposed

(Leaf Healthcare, 2020). This unique technology uses a sensor adhered directly to the patient to

monitor and document wirelessly, in real time, the patient’s position and movement, recognizing

both self-turns and staff-assisted turns. The device tracks the time spent in a specific position and

notifies staff via a central display when repositioning is necessary. The benefits of this

technology include increased prioritization of patient turning with a visual display indicating a

turn is needed, enhanced teamwork among staff without added communication effort, and real-

time documentation of patient positioning. The proposed QI project attempted to reduce the

trending NDNQI rates on the PCU while assisting nursing in adhering to the unit policy of the

every-two-hour turn protocol.

Purpose

As evidenced by the previous two years of data, current practice was not meeting the

benchmark set by CMS in the rate of HAPIs on the PCU. Due to the quality outcomes and

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financial implications associated with HAPIs, there was a need for improvement in the

prevention of HAPIs on the PCU at Mayo Clinic Jacksonville.

This QI initiative was based on the implementation of the Leaf Patient Monitoring

System to reduce the number of HAPIs on the PCU over the three-month implementation period.

The primary objective was proposed to be met by achieving a 70% reduction in HAPIs in

comparison to the six HAPIs that have already occurred in the first half of 2020. The secondary

objective that was measurable and assisted in meeting the primary objective was an improvement

in turning compliance. Baseline turning compliance rates for the PCU were not previously

tracked, however, literature suggests the average turning compliance rates among institutions

across the nation is around 60%, with even lower rates between 38 - 51% in ICUs (Pickham et

al., 2016). This secondary objective was proposed to be met by achieving an 85% turn

compliance rate, which is data that was directly collected from the Leaf technology.

Framework

Theoretical Framework

The QI framework that was used for the implementation of this initiative was a revised

version of the best practice framework (Nelson et al., 2010). The original framework was created

in 2007 to be a model for quality improvement, and targets four areas for success in quality

improvement: leadership; staff; performance and improvement; and information and information

technology. Within each domain are interventions to activate stakeholder participation in the

implementation of evidence-based practice. In 2014 this model was revised by a group of

physicians, nurses, and researchers from two different academic medical centers specializing in

pressure injury prevention to fit the needs of a pressure injury prevention QI initiative. The final

framework considered the four domains of the original framework and adapted the interventions

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to meet the requirements for a pressure injury improvement bundle. The basis of the original

framework is depicted in Appendix B, and the revised framework in Appendix C.

The interventions within each domain are directly parallel to the steps taken for the

implementation of the Leaf Patient Monitoring System. The QI interventions within the

leadership domain include prevention awareness, leadership initiatives, administration support,

and benchmarking. Mayo Clinic stakeholders and administration are aware of the past pressure

injury trends and supported the need for improvement within the PCU. This QI initiative itself

was a direct leadership initiative as the proposed project was fully supported by the unit nurse

manager, quality improvement nurse practitioner, and quality improvement nurse practitioner

within the ICU.

Within the staff domain of the framework, quality interventions implemented for success

included staff meetings, staff training, and prevention education. All three of these interventions

are addressed within dissemination of the QI project. In addition, performance measures are

included that will explain the “why” and the need for staff involvement of this intervention.

The performance and improvement domain includes the use of the Braden Scale as an

intervention, visual tools, and repositioning. These are all aspects included in the intervention.

The Braden Scale documentation by staff every 12 hours per Mayo policy was continued. The

visual tool intervention was incorporated through the Leaf Patient System Monitoring itself and

the central display showing the need for patients to be repositioned. This met the goal of the

framework to establish a formal regimen for patient repositioning.

Lastly, the information and information technology domains are evident within the

intervention through the Leaf Patient System Monitoring and its integration into the current

electronic health record (EHR) at Mayo Clinic. This proposed benefit of the technology would

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have allowed the suggested interventions of data tracking, automatic alarm, and EHR

implementation to be met. In addition, the proposed integration into the EHR would assist in

collecting data to assess the efficacy of the intervention.

Quality Improvement Model

The theoretical framework that was used in conjunction with the QI model was the

implementation method of Plan, Do, Study, Act. This is a tool that is used to organize and

evaluate a change. There are three keys to using this method correctly (Agency for Healthcare

Research and Quality, 2020). The first is evaluating a single step, which was the Leaf technology

for this QI. The next is doing it over a short duration of time, which was the three-month time

period for the QI. Lastly, using a small sample size, which was evident through the

implementation on one unit, the PCU, with hopes for expansion upon success on the QI.

Definition of Terms

Important phrases to understand within this proposed QI initiative are as follows:

1. Pressure injury: This is defined as damage to localized skin or underlying soft tissue that

typically presents over a bony prominence or from a medical device. There are four

stageable types of pressure injuries (1-4), unstageable pressure injuries, and deep tissue

injuries.

2. Hospital-acquired pressure injury or HAPI: This is a pressure injury, unstageable

pressure injury, or deep tissue injury that occurs while a patient is inpatient at a hospital.

3. Unstageable pressure injury: This is a pressure injury in which the base of the wound

cannot be visualized due to eschar or slough. Due to the unknown depth of the wound, it

cannot be categorized or staged.

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4. Deep tissue injury: This type of pressure injury presents as a purple or maroon

discoloration on intact skin or as a blood-filled blister (Cox et al., 2018).

5. Turn period: The Leaf Sensor will be programmed for a turn period of two hours. This

will allow the patient to stay in a single position for two hours and then will trigger the

alert by color on the display monitor to notify that a turn is needed within 15 minutes or

is due now. Once an adequate turn is performed, the technology will reset for another two

hour turn period.

6. Turn angle: This is defined as the rotation degree of the patient in the transverse plane in

relation to the patient’s vertical access (Schutt et al., 2017). The turn angle threshold for

this initiative is set at 20 degrees for all patients. This degree of turn must be met for the

sensor to accept the turn as sufficient and reset the turn period.

7. Decompression time: This is defined by a length of 15 minutes for this project. It means

that the next turn for the patient must give the previous pressure-loaded area on the body

at least 15 minutes before pressure being reapplied. The sensor will not reflect an

effective turn if pressure is reapplied to the same area, resulting in a continued red alert

on the central monitor.

8. Turning compliance: This is defined as a percentage of time that a patient was turned

within a 2-hour time frame. It is calculated by the time a patient was compliant of turning

within two hours divided by the total number of hours monitored. The turn compliance

percentage will be calculated by Leaf technology and provided in data report sheets.

Review of the Literature

A review of the literature was conducted and presented through a literature matrix

detailing the citation, purpose, design, sample, and results from the work (see Appendix D). The

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literature search was conducted through the databases ScienceDirect, Ovid Full-Text Nursing,

CINAHL, and Google Scholar. Keywords searched included pressure injury, prevention, patient

positioning, turning adherence, HAPIs, and Leaf Patient System Monitoring. Articles not

included were works that were completed outside the 5-year publication time frame, included

pediatric patients within the sample, did not discuss the interventions effect on HAPIs/PIs, or

were not published in English. Seventeen articles were selected for analysis to support the

proposed quality, 14 of which were within 5 years of publication. The three articles outside the

5-year publication period describe proper patient turning mechanics and its effect on pressure

injuries.

The main topics to be discussed for purposes of this QI project include literature

discussing different interventions that are common in practice to prevent pressure injuries, as

well as new approaches.

Risk Assessment

A consistent practice that emerged from the literature regarding the prevention of HAPIs

included a risk assessment performed upon admission and reassessed daily (Institute for

Healthcare Improvement, 2020). This practice is supported by governing groups such as the Joint

Commission, the National Quality Forum, and the Institute for Healthcare Improvement. Hodl et

al. (2019) conducted a cross-sectional prevalence study on 532 patients aged 65 years or older

that were at risk for HAPI development to determine if having a risk assessment completed

would lead to increased prevention interventions by nursing. They found that having a risk

assessment (a Braden Scale score in this study) documented is positively correlated with the

implementation of evidence-based interventions, such as the use of moisture/barrier creams for

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skin protection, malnutrition screenings, devices to promote pressure off-loading, and increased

mobilization and repositioning of the patient.

Another important pearl that arose from this study included nursing perceptions that

affect those who receive a risk assessment. The study found that the patients who did have

documented risk assessments were the older, more care-dependent patients within the study. In

contrast, they found that a younger, seemingly mobile patient that may appear to have little to no

risk of developing a pressure injury would be less likely have a pressure injury risk assessment

documented (Hodl et al., 2019). Based on their findings, the authors call for all patients,

regardless of perceived risk, to have a documented risk assessment, as this led to increased

compliance of prevention interventions on patients who otherwise may have been overlooked

(Hodl et al., 2019).

Another group reviewed the implications of a completed risk assessment (Braden Scale)

through a retrospective, descriptive study design (Cox et al., 2018). This study included 57

critically ill patients admitted to an intensive care unit for greater than 24 hours who acquired a

pressure injury during the admission. These patients all had Braden Scale score documented, but

still developed a pressure injury. This study’s findings suggest that a Braden Scale score is

necessary but fails to encompass all components that increase risk for development of the

injuries. Of note, the top two diagnoses out of the 57 patients that developed a pressure injury

were sepsis and respiratory failure, which are two statuses not addressed within the risk

assessment (Braden Scale) used in this study. Other factors such as prolonged intensive care unit

(ICU) admission, medical history including but not limited to diabetes, cardiovascular disease,

hypotension, and the need for mechanical ventilation may also be associated with increased risk

of HAPIs. Thus, critically ill patients who had a Braden Scale score documented and prevention

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strategies in place still developed a HAPI, suggesting that the condition of the patients left little

control over nursing quality to prevent the injury. While Cox et al. agreed that risk assessment

and aggressive prevention strategies in immobile, critically-ill patients is essential, the authors

postulated that some HAPIs were simply unavoidable.

Out of the 57 patients followed in the Cox et al. study, 40 patients, or 70%, developed a

deep tissue injury, (2018). While that study argued that some PIs are simply unavoidable, Li et

al. (2020) argued differently. Their systematic review and meta-analysis included 39 studies

published between 2008 and 2018 and included 2.5 million patients. This review stated that

superficial pressure injuries, stage I and II are the most common PIs to develop in hospitalized

patients, and are, in fact, preventable. The analysis completed by Li et al. emphasized the need

for continued attention to be given to HAPI prevention strategies as the global prevalence from

this extensive analysis proves that HAPIs continue to be a concern despite being unavoidable.

Turn Period

Another current practice discussed in the literature was the appropriate timing for the

patient turn period to give the highest chance of preventing a PI. The Prevention and Treatment

of Pressure Ulcers/Injuries: Clinic Practice Guideline developed by the European Pressure Ulcer

Advisory Panel, National Pressure Injury Advisory Panel, and Pan Pacific Pressure Injury

Alliance addresses the turn frequency within these guidelines (National Pressure Injury Advisory

Panel, 2019). Unfortunately, no exact period for repositioning has been connected with the

prevention of PIs. Instead, the guidelines suggest repositioning all patients with or at risk of a

HAPI on an individualized schedule. Also, it suggests that the risk assessment be done per the

acuity of the patient, with no specific frequency documented. The guidelines, however, did

analyze six level-one evidence studies within the repositioning section and concluded that

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different frequencies of repositioning (2, 3, or 4 hours) were at least somewhat effective at

preventing HAPIs. These guidelines were found to be true within the review of the literature

completed for this proposal (NPIAP, 2019).

Moore, Cowman, and Conroy conducted a multi-center, prospective, cluster-randomized

controlled trial in 2011 to assess the incidence of pressure injuries among older patients using

two different turn periods of 3-hour and 6-hour regimens. The study included two different

groups, the experimental group of 99 patients who were repositioned every 3 hours overnight,

and the control group of 114 patients who were repositioned every 6 hours (Moore et al., 2011).

The results concluded that three patients in the experimental group developed a HAPI compared

to 13 patients in the control group that developed a PI, which was statically significant (p =

0.035) in favor of the experimental group receiving the turn period of 3 hours (Moore et al.,

2011). This study did not address the acuity as the 2019 Clinical Practice Guidelines suggest.

However, it did find a favorable outcome with the experimental group.

Another study approached the turn frequency guidelines differently by using an

alternating approach and then analyzed its cost-effectiveness (Marsden et al., 2015). This study

was a systematic review of clinical data followed by an economic analysis using a cost-utility

model. The study evaluated 235 patients in a long-term nursing home over five weeks. The

sample was split into two groups, with one group receiving every four hours turns from semi-

fowlers to left or right lateral turns and the other group receiving four hours spent in semi-

fowlers followed by two hours in a left or right lateral turn. The results concluded that

intervention two, alternating between a four and two hour turn period, resulted in a reduction in

PIs when compared to the turn period of four-hour group. However, this intervention was not

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cost-effective. This study deemed that the number of prevented pressure injuries was small and

that the resource-intensive cost of this intervention was not cost-effective.

Multicomponent Interventions

Many studies within the literature review implemented a group of interventions to

prevent HAPIs. Shieh et al. (2018) performed a quality improvement project taking into account

risk assessment and other factors that can affect pressure injury development to implement a

multicomponent order set. The quality improvement project was implemented at two different

facilities between 2013 and 2016. The project intervention was a pink paper reminder system

that hung at the head of the bed for patients deemed at risk. The patients were deemed at risk in

one of two ways: a Braden score of less than or equal to 12, or a Braden score less than 18, plus

two of the following: older than 65 years of age, albumin level of less than or equal to 3.0 g/dL,

partially blanchable skin, irritant dermatitis, or the presence of a pressure injury. If the patient

qualified for the pink paper intervention, the nursing interventions included a sacral dressing,

heel protectors, a turn period of two hours, and a skin assessment every shift. The initiative

resulted in a 67% reduction in HAPIs when comparing data from 2009-2012 to 2013-2016. It

also showed a statistically significant reduction from 84 HAPIs over 101,600 patients days in

2013 to 32 HAPIs over 123,187 patient days in 2016. There are no data within the study to show

that one intervention was more effective than the other. However, it does follow many guidelines

discussed in the Clinical Practice Guidelines 2019. Another aspect to note within this study was

the intentional targeting of a smaller percentage of patients to qualify for the pink paper

intervention with the thought process that if all patients qualified, nursing would become

desensitized to the warning.

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A systematic review by Lin et al. (2019) revealed many more studies that chose to

implement a multicomponent pressure injury prevention package. A total of 21 peer-reviewed

papers (12 quality improvement projects and nine research papers) were included within the

review, with the number of prevention interventions between two and 11 (Lin et al., 2019). The

most common components implemented included clarification of staff roles, introducing new

roles, repositioning, staff and patient education, support surface use, pressure injury risk

assessment, skin assessment, nutrition needs assessment, documentation, multidisciplinary team

involvement, and mobilization. 12 of the 21 studied papers implemented a repositioning

intervention, 14 of the 21 implemented a risk assessment, and 16 of the 21 applied staff

education. The outcomes from all 21 studies were positive, but they did vary on the measurable

outcome. Five out of the nine research studies reported a significant reduction in pressure injury

prevalence, while the other four reported a favorable trending data toward reduction. Two

quality improvement papers reported savings of close to $1 million after the implementation of

the prevention strategies. Three studies reported increased compliance of prevention strategies.

Due to the positivity of outcomes that came from the studies, Lin concludes that implementation

of prevention programs for HAPIs are beneficial.

Another multicomponent intervention prevention strategy was analyzed through a quality

improvement project by Yilmazer and Bulut (2019). This initiative took place in an ICU to

determine the effectiveness of a pressure injury prevention algorithm on the prevention of

pressure injuries. The study included two sample groups, a pre-algorithm group (n = 80) and a

post-algorithm group (n = 74). The prevention algorithm was just that, an algorithm to guide the

care for prevention. If the skin was intact, daily skin assessment and daily Braden scale scoring

remained the standard of care. If the skin was not intact, with any type of inflammation, moisture

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or incontinence damaged skin, induration, or any skin loss, the nurse would continue on the

algorithm to determine if the injury was related to pressure, the stage of the injury, and the best

interventions to implement. The interventions at the end of the algorithm included the topics of

skincare, activity management, nutrition management, moisture/incontinence management, and

support surface management, with different interventions listed under each item. Of note, the

interventions included a turn period of two hours. The initiative revealed a statistically

significant positive outcome with a post-algorithm result of 9.21 PIs per 1,000 patient days in

comparison to the pre-algorithm prevalence of 46.10 pressure injuries per 1,000 patient days.

The study also evaluated staff feedback on the implementation of the algorithm and found that

73.3% of staff felt that the algorithm was sufficient, necessary, and useful for prioritizing

prevention measures throughout the shift.

Patient Monitoring Technology

In this section, nine works of literature will be discussed. The first four emphasize needs

in pressure injury prevention that the Leaf Patient Monitoring System can support directly. The

next four works include studies with the implementation of the technology. The final piece of

literature is an editorial that also addresses topics that can be related to success that can stem

from the technology implementation.

The first piece of literature to discuss here is a cost-utility analysis to compare the cost-

effectiveness of implementing pressure injury prevention-for-all patients versus ‘risk-stratified

prevention’ versus standard care (Padula et al., 2018). Risk-stratified prevention in this context

meant providing additional prevention interventions based on the Braden score of the patient.

Standard care was defined as intentional prevention of pressure injuries, but with no additional

interventions introduced. A Markov model was used to determine cost-effectiveness. It

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compared six different possibilities of prevention: prevention-for-all, with risk-stratified

prevention for patients that fell below a Braden score of 19, patients that fell below a Braden

score of 15, patients that fell below a Braden score of 13, patients that fell below a Braden score

of 10, and standard care. The results showed that prevention-for-all was most cost-effective

when compared with risk-stratified and standard care prevention.

Prevention-for-all produced higher quality-adjusted life years at a slightly higher cost, but

it yielded an incremental cost-effectiveness ratio of less than $100,000, meaning that the

difference was insignificant. The study explains that the prevention-for-all strategy was found

within this study for various reasons. The first being that a patient who could be identified as

low-risk has a reasonable chance of transitioning into a higher-risk category depending on any

status changes in the patient (Padula et al., 2018). Additionally, the thought of applying

prevention-for-all would cause this to become the new standard of care, thus decreasing costs

from this perspective. A limitation of the study is that there is no direct explanation of what

prevention-for-all is, but alludes to nursing hours spent for prevention, pressure-distributing

beds, and skincare or moisture management. Despite this limitation, it is reasonable to conclude

that the study suggests prevention-for-all provides better financial health to the institution as

opposed to risk-stratified prevention or standard care prevention.

The article discussed above ties directly into the next article. Saindon and Berlowitz

(2020) analyzed six articles published between 2018 and 2019 that brought forward important

“pearls” in terms of pressure injury prevention. In fact, the article by Padula et al. discussed

previously was one of these six. In addition to this article, one other article referenced pressure

injury prevention strategies are cost-effective for institutions. The article called for investment in

specialty mattresses, as this revealed a reduced incidence of PIs and had higher quality-adjusted

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life years (Nixon et al., 2006). Despite specialty mattresses not being the focus of this initiative,

it is apparent that investing in some sort of pressure injury prevention does bring about better

financial outcomes for institutions.

The next article is a descriptive, cross-sectional survey completed by healthcare workers

at institutions across Canada (LeBlanc et al., 2019). The purpose of the survey was to describe

HAPI prevention among different institutions, as well as identify opportunities for improvement.

The survey focused on the attitude of respondents toward PIs, the awareness of HAPI prevention

strategies, and practices implemented for prevention. The survey revealed that 85% of

respondents care for patients with pressure injuries, 90% confirmed awareness of prevention

devices, and 80% confirmed using these devices. The survey also revealed perceived pressure

injury prevention implementation barriers to include high nurse-to-patient ratios, resource

constraints, and less-than-optimal implementation of evidence-based practice. The conclusion

from this survey is the evidence of a disconnect between awareness of pressure injury prevalence

and strategical implementation to prevent pressure injuries.

An important aspect of pressure injury prevention is pressure itself. Peterson et al. (2010)

evaluated the effects of patient turning on skin-bed interface pressures through an observational

study using 15 adult employees at a university-affiliated hospital. The study was conducted using

sensor pressures from different positions of 15 adults who varied in age, weight, and body mass

index in a patient bed. Experienced intensive care unit nurses simulated patient turns on the

employees into the supine and lateral positions using pillow support, wedge support, and

different head-of-bed elevations. The results showed that raising the head of the bed to 30

degrees increased peak interface pressures with statistical significance. The study also revealed

that increased pressure developed when a wedge was used to reposition rather than a pillow.

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Another key point was an increase in pressure as weight and body mass index, but not height.

The overarching conclusion from this study was that despite the experience level of the staff

repositioning patients, there is not enough pressure off-loading to prevent skin breakdown and

pressure injuries. A limitation of this study is the date of publication a decade ago. However, the

information presented regarding skin-bed pressure would not be affected over time.

The next article is a randomized clinical trial that evaluates patient turning and the effect

on HAPIs in acutely-ill patients (Pickham et al., 2018). The trial has a sample of 1,312 patients

from two intensive care units assigned to either a control group or treatment group. The control

group of 653 patients received standard care practices that are in place within the unit. This is

explained within the study as pressure injury prevention “activities” but is not defined any

further. The treatment group of 659 patients received the implemented pressure injury prevention

intervention of turning every two hours with tissue decompression of 15 minutes. Both groups

were monitored with the application of a wearable patient sensor, a proprietary technology of

Leaf Healthcare. The primary outcomes of the study include the difference in compliance rates

of turning between the control and treatment group, as well as the prevention of pressure injuries

between the two groups. In total, there was 103,000 hours of monitoring data collected from the

wearable sensor between both groups. The intervention group showed statistically significantly

fewer HAPIs than the control group with 5 and 15 HAPIs occurring in each group respectively (p

= 0.031). In terms of the turning compliance, the treatment groups turning compliance was 67%

compared to the control group turning compliance of 54%. The conclusions based on this clinical

trial revealed that optimal turning and improved turning compliance time was effective in

reducing HAPIs.

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The next study examines the implementation of the patient monitoring device in a

nursing home setting and its effect on pressure injury prevention (Yap et al., 2019). The sample

included 44 residents that were monitored through the Leaf Sensor application for a range of two

to 21 days. The technology proved to significantly improve compliance with a turn period of two

hours for every patient (p = .0003). In addition, no new pressure injuries developed throughout

the study. The study also assessed staff perception of the technology using the Nursing Culture

Assessment Tool (NCAT). The results of the NCAT were not statistically significant, but they

did show improved teamwork and communication among staff with the implementation of the

technology.

The technology was successful in a long-term nursing facility and was also proven to be

successful on a medical unit in a community hospital (Schutt et al., 2017). This study again

evaluated the continual patient monitoring device (Leaf Sensor), but it used compliance with

patients turning every two hours as the measurable outcome. The sample included 138 patients

and a total of 7,854 hours of patient positioning data. The baseline data were derived from a

sample of 75 patients who had a sensor in place without a turning intervention. The post-

intervention sample of 63 patients also had the sensor in place and experienced staff-assisted

turns every two hours if the patient's self-turn was not a compliant turn, as evidenced by the

technology within the sensor. The study showed a baseline turn adherence of 64%, while the

post-intervention group showed a turn-adherence of 98%, which was statistically significant (p <

.001).

The final study examined was completed by Doucette et al. in and was found on the Leaf

Healthcare webpage. The purpose of this randomized controlled trial was to assess the use of

Leaf technology on turn adherence. Sixty-nine patients on a medical-surgical unit, which has a

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two hour turn period implemented on every patient as standard care, were monitored for 31 days

using the technology. The compliance of the turn period of two hours was calculated by the time

the patient was in accordance with the two-hour turn period divided by the total time the patient

was monitored. A total of 3,287 hours were monitored for all 69 patients. The average amount of

time monitored per patient was 47 hours. The study resulted in turn compliance of 88.5%.

The last piece of literature to be discussed in this review is an editorial written by Dr.

Joyce Black, who holds her Doctor of Philosophy in nursing and is also a certified wound care

nurse. Dr. Black discusses the 2014 International Clinical Practice Guidelines on pressure injury

prevention, as well as the clinical practice guidelines for prevention developed by the American

College of Physicians (ACP). Dr. Black pointed out that the 2014 International Clinical Practice

Guidelines contain only 77 statements with evidence-based literature as support, and the

remaining 498 statements are based on expert opinion (2015). Dr. Black then introduces the

guidelines written by the ACP, which are based on systematic reviews funded by The Agency for

Healthcare Research and Quality (2015) and contain only recommendations for the prevention of

pressure injuries based on supporting studies. She examined the differences between the two

sources to emphasize that there is a need for pressure injury prevention strategies founded in

literature and not just based on expert opinion due to the absence of valid evidence. She makes

two very valid points that are of value to this initiative. The first being that any type of pressure

injury risk assessment is of low sensitivity and specificity because the risk of the patient can

change within minutes based on the patient’s condition. This is a strong supporting statement for

the Leaf Patient Monitoring System as it is monitoring the patient continually, not for risk

assessment, but for ensuring that the patient is not put at a higher risk due to the patient’s

position (Black, 2015). Second, Dr. Black attributes the success of multicomponent prevention

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strategies to the engagement of leadership and administration, the involvement of direct care

providers, continuous education of staff, and sustained audits and feedback. The topics to which

she attributed success are all components that are proposed for implementation with the use of

Leaf technology.

Synthesis of Findings

The following is a summary of the findings from the review of the literature that was

applied in this QI project. The first suggestion was that risk assessments are necessary for all

patients (Hodl et al., 2019). Two other articles contained opposing views that risk assessment

does not assist in preventing unavoidable pressure injuries versus the conclusion that risk

assessment does help to prevent stage I and II pressure injuries (Cox et al., 2018; Li et al., 2020).

Taking into consideration the suggestions from this evidence, risk assessments using the Braden

Scale upon patient admission and every shift as the standard of care continued throughout the QI

as the literature shows evidence that they are effective in the prevention of pressure injuries.

Next, based on the literature reviewed for different turn frequencies, there was not a

specific turn period that had proven to be directly preventative of pressure injuries (Marsden et

al., 2015; Moore et al., 2011; Prevention and Treatment of Pressure Ulcers/Injuries: Clinic

Practice Guideline, 2019). Due to this, the implementation site standard care of every two hour

turns for patients, in addition to the turn period put in place in articles discussed above, 2 hours

remained the turn period for the QI (Doucette et al., 2014; Pickham et al., 2018; Schutt et al.,

2017; Yap et al.; Ly, 2019).

The next synthesized piece of evidence from the literature concludes that financial

investment into pressure injury prevention is cost-effective (Marsden et al., 2015; Padula et al.,

2018; Saindon & Berlowitz, 2020). Despite the evidence investing into various pressure injury

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prevention strategies, the overall theme among the literature is that pressure injury prevention is

cost-effective, therefore, supporting the investment into the Leaf Patient System Monitoring for

this quality initiative improvement.

Another piece of evidence founded in literature is that multicomponent pressure injury

prevention strategies are effective (Lin et al., 2019; Shieh et al., 2018; Yilmazer & Bulut, 2019).

While this quality initiative is not proposing to implement a multicomponent approach for

pressure injury prevention, the site of implementation does already use aspects of the

multicomponent approach as the standard of care, such as moisture/incontinence care, nutritional

management, and early mobilization. This piece of the literature, however, is an important aspect

to acknowledge for future prevention strategies.

Lastly, it was evident in the literature that the implementation of the Leaf Patient

Monitoring System is producing successful outcomes in terms of turn compliance and pressure

injury prevention (Doucette et al., 2014; Pickham et al., 2018; Schutt et al., 2017; Yap et al.,

2019). From these recent studies within the literature, this proposal is a promising testament to

stay on the cutting edge of research for the proposed implementation site and to improve patient

outcomes in terms of pressure injury prevention.

Project Description

The Leaf Patient Monitoring System was implemented on the progressive care unit

(PCU) at Mayo Clinic Jacksonville and analyzed over a three-month time period to assess the

technology’s effectiveness on reducing HAPIs.

Outcomes

The first proposed outcome was to reduce HAPIs by 70%. The comparison for meeting a

70% reduction is to the beginning of 2020 when the PCU already took responsibility of 6 HAPIs.

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In order to meet this outcome of the QI, the PCU must decrease by 70%, or by 4.2 HAPIs. This

comes out to being no more than 1.8 pressure injuries, which would round down to 1 pressure

injury throughout the three-month time period. The technology intended to assist in meeting this

goal through the color change alarm on the central monitor telling staff that the patient is due to

be turned, as well as through the technology taking into account turn angle allowing for tissue

reperfusion, which are both preventative measures for HAPIs.

The second proposed outcome was to improve the turn compliance on the PCU to 85%.

This meant that patients being monitored with the Leaf sensor would be repositioned every two

hours, a current unit policy, 85% of the time. This percentage result was calculated by the

technology using the number of hours monitored and the early, late, or on-time turning that took

place to provide an average of the turning compliance on the unit. This data was provided by the

technology company in daily, weekly, and monthly reports (see Appendix E). Prior to the QI,

there was no baseline data in which to compare the post-intervention turn compliance. However,

data suggests the average turn compliance across institutions in the nation is 38% - 66% (Leaf

Healthcare, 2017). Therefore, the second measurable outcome was to improve the turning

compliance to 85% on the PCU.

Intervention

The QI initiative was based on the implementation of the Leaf technology on the PCU.

The Plan, Do, Study, Act was the quality model that was followed for implementation.

Technology

The Leaf Patient Monitoring System is a proprietary medical software developed by Leaf

Healthcare to prevent hospital-acquired pressure injuries (Leaf Healthcare, 2020). It is composed

of a lightweight, wireless, wearable patient sensor and a central monitor that displays patients’

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positioning and movements (see Appendix F) through the use of secure antennas installed within

the unit that will directly communicate and document within the EHR used at Mayo Clinic. This

technology gave the PCU the opportunity to reduce the HAPI prevalence within the unit and

increase turning compliance. The central monitor display showed the room number, patient

initials, time until next turn, and current position (see Appendix G). The time until the next turn

is displayed using three colors: green, meaning the patient is in a good position; yellow,

indicating that repositioning is necessary within 15 minutes; and red, meaning that the patient is

overdue for repositioning. The Leaf Patient Monitoring System technology also takes into

account the turn angle to ensure that the turn is effective enough for pressure off-loading and

tissue reperfusion between turns.

Plan

The planning phase began in June for the quality initiative. The first step was reviewing

previous data of pressure injury prevalence on the PCU to prove a need for improvement.

Key Stakeholders

The next step was obtaining stakeholder commitment for implementation of the Leaf on

the PCU. This was done by crutching on the trial of the Leaf Patient Monitoring System that was

completed at MCF on both intensive care units in 2019 and has since been implemented as a unit

specific standard of care. Due to the success in the ICUs, the technology has been approved by

MCF and has gained administration, physician, and nurse-manager approval for implementation

on the PCU. Specifically, the clinical project manager for the ICU implementation is a Doctor of

Nursing Practice (DNP) specializing in quality at MCF. Another stakeholder that will be key to

QI project implementation is the nurse manager of the PCU who has also approved the project

implementation.

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The Leaf Patient Monitoring System has been thoroughly vetted and approved by the

administration for implementation within the PCU following the successful pilot in the ICU (see

Appendix H). The success of the ICU pilot, which demonstrated a reduction in HAPIs by 65%

and a projected financial savings profile of three million dollars a year based on the 2018 HAPIs

costs, are two of the influencing factors for expanding to the PCU.

Setting and Population

Due to the success of the trial in the ICUs at Mayo Clinic, the PCU, or step-down ICU,

was the logical next location for implementation. The PCU is a 27-bed unit composed of

critically ill patients. The census of the PCU is typically 24-26 patients a day with an average

length of stay of 5.4 days. The most common diagnoses on the unit include sepsis, congestive

heart failure exacerbation, chronic obstructive pulmonary disorder exacerbation, lung transplant,

and gastrointestinal bleeding. Many patients have impaired mobility due to illness or injury,

some requiring mechanical ventilation, or immobilization, rendering them unable to prevent a

potential pressure injury by turning independently. It was projected that 3-5 patients will be

monitored at any given time. Taking into account the average length of stay on the PCU, there

was projected to be about 15-30 patients a month that would be monitored on the sensor.

Application guidelines for use in the PCU were carried over from the ICU to ensure continuity

despite some interventions (such as vasopressors) not applicable to the PCU. The application

criteria pertinent to the PCU included: a pressure injury on admission, history of PI, a body mass

index of greater than 35 or less than 18, a Braden Scale score of less than 13, a stable spinal cord

injury, a rectal tube in place, moisture-associated skin damage, incontinence-associated

dermatitis, lower extremity flaccidity, and nursing judgement (see Appendix I). Patients who did

not qualify for the sensor included those with broken, irritated, or infected skin at or near the site

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of placement, a known allergy or sensitivity to medical-grade adhesives, a sternotomy incision

within the last seven days, and those who had an open chest wound. A quick reference guide or

“badge buddy” with the application criteria was given to each staff member to allow for easy

reference and evaluation of patients upon admission or transfer to the unit (see Appendix J).

Education

A large part of the planning phase included the education that was completed by the staff

on the PCU. This included nurses, PCTs, and health unit coordinators (HUCs). The first piece of

education was the eLearning provided by Leaf Healthcare. The vendor education session was

assigned to all staff within the MCF intranet. All staff was expected to complete this training

before the go-live date. The eLearning consisted of an 11 minute and 15 second training video

that demonstrated how to apply a Leaf sensor, register a patient, interpret the display, remove a

patient from the central display, and turn and reposition a patient effectively. The eLearning was

concluded by a 10-question multiple-choice exam that required an 80% pass rate for the

completion of the course. The data related to the completion of the education exam was not

recorded or of any use for the QI intiative, rather a step to prepare the staff for prior to

implementation.

The DNP student also worked with Leaf Healthcare staff to determine a schedule for

bedside in-service trainings the week prior to go-live. These trainings consisted of a 10-minute

in-service education led by the Leaf representatives for all nurses, patient care technicians, HUCs

on the use, application, and interpretation of the technology for efficient use. Staff was

responsible for attending the required education “drop-in” sessions without going above FTE.

The education sessions lasted only 10 minutes and was offered over 1 week, allowing staff to

attend during a scheduled shift and not go above the FTE. The completion of the in-service was

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ensured through a sign-in sheet. If a staff member was absent or unable to attend the session, the

DNP student gave an overview of the in-service to the specific staff member.

The HUCs also received an additional three-minute in-service regarding how to register

patients once a Leaf sensor is placed on the patient and the expected communication work flow.

The work flow was developed by the DNP student (see Appendix K). When the central display

indicates a patient is due for a turn in 15 minutes by turning yellow, the HUC was instructed to

send a text through the secure chat in Epic to the nurse and PCT. If the patient is not turned and

became overdue for a turn, indicated by turning red on the central display, the HUC was

instructed to call the nurse and PCT. If the patient was still not turned and was then 15 minutes

overdue, the HUC was instructed to call the TL to assist the nurse and PCT in getting the patient

turned. A copy of this workflow was laminated and located at the central monitor for easy access

by the HUC or any staff that looked at the monitor.

In addition to the floor staff being educated about the Leaf technology, the wound care

department was also involved. This department had already been educated on the Leaf

technology due to the implementation in the ICUs previously. The education needed for

implementation on the PCU included the communication workflow if a HAPI developed

throughout the study period. The protocol regarding a patient that is admitted with a pressure

injury or develops a HAPI during the hospitalization will still stay in place (consult to the WOC

team, notification to the provider, and consent to photograph the wound). If a HAPI did arise

during the QI period, the WOC nurse was to send an email communicating to the nurse manager,

which is current practice, and additionally include the DNP student about the presence of the

HAPI acquired during the hospitalization. The email communication did contain patient-

identifying information which is current practice and of use to the nurse manager, however, the

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DNP student did not keep track of any patient-identifying information. The DNP student only

used this communication to keep track of the HAPIs that occured throughout the intervention

time period.

Fiscal Consideration

The equipment needed for the implementation of the technology included the Leaf

Sensor, Leaf Antenna, and Leaf Dashboard. The Sensors had previously been invested in by

Mayo Clinic with an initial investment of 50 sensors for $200 each, which equated to about

$10,000 previously spent on sensors. The antennas, dashboard, and staff educational modules

were of no cost for implementation of the product. The installation of the technology was

completed within the scope of the information technology (IT) department, incurring no

additional costs on labor for the institution.

The educational module provided by Leaf included an 11-minute video with a post-test

that took staff a total of 20 minutes to complete. In addition to the eLearning, the bedside in-

service provided by the Leaf was completed in a 10-minute time period. These were both done

during a scheduled shift, however, for the effort expended by staff over the expected 30-minute

time period it took to complete both education requirements, it costed the institution around

$1,070. This calculation came from a half-hour of labor from 57 nurses averaging $30/hr, 24

PCTs averaging $15/hr, and 5 HUCs averaging $15/hr.

Confidentiality

There was no breach in the Health Insurance Portability and Accountability Act

throughout the entire process for the QI project as no patient identifying information was

recorded. All patients who qualify for sensor application were only tracked by the WOC nurse,

who reported on HAPIs as part of the current practice. If a HAPI did occur, the WOC nurse

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reported this to the nurse manager with details about the occurrence, which will now include

whether a Leaf sensor was in place or not. The DNP student also received this information,

however, the only data collected through the communication was that the HAPI occurred and

whether or not a Leaf sensor was in place. A running total of HAPIs was kept in a secure Excel

spreadsheet within the Mayo Clinic secure network during the QI (see Appendix L).

In addition, the data transmitted from the sensor to produce daily, weekly, and monthly

unit results contained no patient identifying information and was encrypted within the Mayo

Clinic secure network. The only data that was recorded from the report sheets produced by the

sensors for the QI initiative was the turning compliance percentages for the PCU during the

three-month time period. The compliance percentages were also recoded in an Excel spreadsheet

and kept within the Mayo Clinic secure network (see Appendix M).

Institutional Review Board Plan

The QI initiative met the criteria for facility IRB exemption due to less than minimal risk

with pressure injury prevention interventions. The Mayo Clinic IRB Wizard was used to prove

exemption (see Appendix N). The appropriate forms were completed for review at Jacksonville

University IRB as a quality improvement project. The QI was cleared by IRB on December 18,

2020 (see Appendix O).

Do

After the installation of technology, required eLearning, and bedside in-service education

was completed, the technology went live on the PCU. Staff used the Leaf workflow to guide

communication regarding the turning requirements, which was adhered to the central monitor for

easy access. Nurses that admitted or received a transfer patient that qualified for the application

of the sensor will receive a sensor from the team lead (TL). The TL is required to do a two-

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person skin check with the admitting nurse at time of arrival to the unit, therefore the TL was

responsible for bringing the Leaf sensor and encouraging its application if appropriate (see

Appendix I). The nurse then documented in the integumentary section on the report sheet that is

passed between nurses during shift change that the patient had the Leaf Sensor in place.

The DNP student initially received daily and weekly reports emailed from Leaf to ensure

the effective use of the technology by evaluating turn compliance time. Further intervention,

such as more education, was available if felt necessary by leadership or DNP student. The DNP

student also was available as a resource in person or by phone, in addition to the Leaf Healthcare

staff who was on-site during implementation the whole week of implementation, then weekly

after go-live.

Measures

During the three month implementation period, the DNP student was responsible for

keeping track of any HAPIs that developed to measure the first objective of a 70% reduction in

HAPIs. There were 6 HAPIs in the first five months of 2020, equaling 1.2 HAPIs a month. With

an average of 25 patients a day and an average length of stay of 5.4 days on the PCU, this

calculated to be about 140 patients per month. This made the incidence rate of HAPIs for the first

five months of 2020 equal 0.008. Once data is collected, the incident rate will be calculated by

using the average occurrence of HAPIs over the three-month time period divided by the total

number of patients monitored by the Leaf (see Appendix L). The goal will be met for this

objective if the calculated rate for the three-month time period is less than or equal to 0.0056, a

70% reduction in the incidence rate from the 0.008 rate calculated for the first five months of

2020. It will also be evaluated with a corresponding 95% confidence interval.

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The DNP student will also keep track of the monthly turning compliance percentage for

the unit resulting from the Leaf technology report sheets. This will be calculated using the

number of patients monitored on the Leaf per month (15-30 patients estimated) and the average

length of stay for each month. This will give the total number of patients days, then will be

multiplied by 12 turns (every 2 hours in a 24 hour day) to give the total number of turns that

should take place. The report sheet provided by Leaf will give a percentage for the turning

compliance which will then be used to calculate the actual turns that took place. The percentages

for the three months will be kept in an Excel spreadsheet to easily calculate the average of the

turning compliance over the three months to assess whether an 85% compliance rate was met or

not (see Appendix M).

Study

After the three-month evaluation period, the DNP student analyzed the data collected

throughout the intervention.

Evaluation Plan

The first outcome for the QI initiative is a 70% reduction in HAPIs on the PCU. In order

to meet this goal, the PCU must not be responsible for any more than one HAPI throughout the

three-month time period. This would be meeting the goal of a 70% reduction in HAPIs in

comparison to the six HAPIs that already occurred in the beginning of 2020. This achievement is

also in alignment with the NDNQI national mean and would incur no penalty on HAPI

reimbursement from CMS. This will be analyzed by addressing the Excel spreadsheet keeping

track of the running count of HAPIs throughout the three months (see Appendix L).

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Secondly, a turning compliance goal of 85% on the PCU is the next measurable outcome.

This will be evaluated using the average of the turning adherence percentages reported from the

statistics generated by Leaf. The data generated from the sensor will be reported to the DNP

student in a monthly report sheet (see Appendix E). The average of the three-month turning

compliance results will be calculated to determine whether an 85% turn compliance goal was

met or not (see Appendix M).

Act

Sustainability

The sustainability of this project will be evaluated once the three-month evaluation period

is complete. If the occurrence of pressure injuries are reduced and turning compliance is

improved, it will show that the Leaf Patient Monitoring System is effective. If this is the case, the

DNP student will present the data to the nurse manager of the PCU regarding the possibility of

continuing with the use of the technology. The DNP student will also make recommendations for

expansion to other units within the hospital. This will lead to further savings from HAPIs for

MCF and provide better outcomes for patients regarding preventable HAPIs. The DNP student

will also submit the final findings for publication and complete a DNP Final Defense

presentation.

Timeline

Below is an overview of the timeline for the QI initiative. It began in June 2020 and will

have a projected completion date of February 2021.

June 2020 – December 2020 (Preparation)

• Evaluate the need for improvement on PCU related to past pressure injury data

• Buy-in from stakeholders

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o Chief Nursing Officer

o Quality Nurse Practitioner

o PCU Nurse Manager

o WOC Team Lead

o Information Technology Manager

o Leaf Healthcare

• Complete proposal for implementation

o Review of Literature

o Project implementation plan

o Statistician consultation

o Create patient inclusion criteria

• Achieve IRB exemption from Jacksonville University and Mayo Clinic

• Technology installation by Leaf Healthcare

• Staff education

o Assigned e-learning course

o 10-minute in-service led by Leaf Healthcare staff

December 2020 – March 2021 (Implementation)

• Implementation of Leaf Patient Monitoring System on PCU

• Follow daily, weekly, and monthly reports generated from Sensor data

• Communication with WOC following HAPI data

• Intervene where needed for staff proficiency with the use of technology

March – April 2021 (Evaluation)

• Evaluate three-month data

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o Turn compliance

o Pressure injury prevalence

• Present findings to Jacksonville University DNP board

• Present the findings to Mayo Clinic (QI personnel, NM, and PCU staff)

• Submit findings for publication

• Upon results, determine dissemination onto other units within the hospital

Findings

The data collection included 24, 21, and 23 patients monitored respectively in the first,

second, and third set of four weeks throughout the three month time period. This equals a total of

68 patients monitored on the Leaf technology, within in the estimated number of 45 – 90 patients

included in the QI project. All patients included were admitted to the PCU at MCF, at least 18

years of age, and verbally agreed to allow staff to place the sensor on their chest for improved

turning compliance purposes based on the inclusion criteria and nursing judegement.

Objectives Met

The first objective proposed to be met with the QI was to reduce PIs by 70% which was

successful as evidenced through the incidence rate of 0 (see Appendix P). Throughout the three-

month data collection, there were zero documented pressure injuries related to turning on the

PCU. There were 7 pressure injuries that were responsibility of the PCU, hwoever, these

pressure injuries were due to medical devices, such as ace wraps on lower extremities and

respiratory equipment, that the Leaf technology was not meant to intervene with. An interesting

correlation found was that 6 of the 7 patients that developed medical-device related pressure

injuries had a Leaf sensor on throughout the hospitalization, but did not develop any HAPIs

related to turning.

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Objectives Not Met

The second objective proposed to be met throughout the implementation of this QI was

an overall turning compliance of 85%. This data was collected through daily reports generated

by the Leaf technology company and analyzed to produce an average over the three months. The

PCU had an average turning compliance of 76.67%, therefore not meeting the proposed outcome

(see Appendix Q).

Data Analysis

HAPI Data Analysis

The HAPI prevalence data was analyzed to evaluate if a 70% reduction in HAPIs

occurred or not. The objective was met if there is an incident rate less than or equal to 0.0056,

which comes from a 70% reduction of the 0.008 incidence rate calculated from the first five

months of 2020. Using the amount of patients monitored throughout the three-month data

collection time period, 68 patients with an average length of stay of 5.4 days totaled 367.2

patient days to evaluate, in comparison to the 675 patient days from the beginning of 2020 with 6

HAPIs. The 95% confidence interval for data pre-Leaf implementation based on a Poisson

distribution is (0.00326, 0.0193), or 3.26 – 19.3 events per 1000 patient days. The 95%

confidence interval for post-Leaf implementation based on a Poisson distribution is (0.0,

0.01004), or 0 to 10.0 events per 1000 patient days. Due to these intervals overlapping, there is

not a statistical difference at the 5% level of significance, however evidence does show a

difference (see Appendix R). In addition, the objective of a 70% reduction in HAPI occurences

was met with an incidence rate of 0.

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Turning Compliance Data Analysis

The turning compliance data was compiled from daily report sheets generated by the Leaf

technology company. Each daily turing compliance rate was kept track of in an Excel data spread

sheet by the DNP student. The monthly average and three-month averages were calculated using

simple arithmetic. The monthly compliances were 77.75%, 72.5%, and 79.75% resptively for the

first, second, and third four week sets during data collection. The overall average for the three-

month time period was 76.67% (see Appendix Q). Evaluating the data in quantiles shows that the

85% turn compliance goal was only met about 25% of the days during the data collection (see

Appendix S). Examining the data on a day-to-day basis shows the beginning and end with higher

daily turning compliances and the midle with lower compliance, in addition to two days of

outlying data (see Appendix T). The graphic examining the day-by-day data tells an interesting

story that the DNP student poses some explanation for in the next sections.

Facilitators and Positive Outcomes

The revised best practice framework that focused on pressure injury prevention was seen

greatly throughout the QI implementation period and assisted with the positive outcomes of the

QI greatly. Within the leadership and staff domains, many examples were seen throughout the

implementation period that respresented the ideas within these domains. Examples of staff

involvement that led to success started with the started with completion of the eLearning module

on the Leaf technology and attendance of the bedside in-service trainings, which both had 100%

completion rates on the PCU. The basic understanding of the technology and potential of

reducing PIs on the unit was greatly received by the staff. Secondly, a key facilitor of the QI was

the involvement of the nurse manager and team leaders on the unit, directly related to the

leadership domain of the framework used. This leadership group encouraged and educated the

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rest of the staff to initiate the Leaf sensor on appropriate patients, as well as troubleshoot when

necessary. Two examples of leadership involvement included adding the Braden Scores of the

patients on the unit to the team lead EMR view in order to facilitate the usage of the Leaf on

patients who had lower braden scores and increasing the number of pillows and wedges available

to staff at the beginning and throughout implementation to ensure the resources needed to

properly turn patients were available. These leadership examples are directly related to the

success of the initiative.

Another facilitator was the functionality that allowed staff to watch their patients on their

personal computer for the day, instead of having to walk to the central monitor displays at the

front and back of the unit. This allowed staff to constantly be aware of how much remaining time

was left until a patient needed to be turned. This successful aspect of the QI can be directly

accredited to the performance and improvement domain of the best practice framework that was

in use.

Some unintended positive outcomes throughout the QI time period was an overwhelming

sense of teamwork and communication. The HUCs were in constant communication with the

nurse and patient care tech regarding the patients that needed to be turned, as well as the nurse

and patient care technicians in communication amongst themselves. A major example of

teamwork was evident when a nurse or patient care tech would notice that a patient was due for a

turn and completed this task, not even being the primary caregivers for the patient. Both of these

improvements created a more positive work environement.

Barriers and Negative Outcomes

The most prevalent barrier throughout the QI project was user error when the patient

would either refuse a turn or when the patient was off the unit. A function on the central monitor

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display would allow the sensor to be paused, which would keep the overdue turn from affecting

the turing compliance, that was not well-understood by the HUC or staff and was rarely used

appropriately. The second barrier, which is greatly connected to the first, was when only one or

two patients were monitored at a time. This meant if that one or two patients was overdue for a

turn, either due to true lack of turning by staff, patient refusal, or patient being off the floor, the

turning compliance would plummet. This is the believed explanation for the outliers of 25%

turning compliance rates for two different days in the data analysis.

A second barrier was a lack of understanding of how to troubleshoot when a turn would

not register. Many times when the turns would not register as a turn it was due to the patient not

being turned far enough, and when the DNP student or team leader would assist the staff in

turning the patient, the turn was accounted for. This specific barrier did decrease toward the end

of three-month time period as staff learned the degree to turn a patient in order to achieve a full

turn.

Another barrier that was unexpected was the delay in communication between the Leaf

technology and the electronic medical record used at MCF. It was understood that the Leaf

technology would chart in the EMR when a patient was turned, however, this function was not

available at time of implementation or throughout data collectio on the unit. It is expected to be

interfaced with the EMR at some point this year. This was a frustrating factor as it could have

improved staff satisfaction and usage of the technology greatly. Unfortunately, this was the key

functionality of the technology that upheld the information and information technology domain

of the best practice framework that was not met.

Lastly, the DNP student believes the middle time period of data collection, which showed

less compliance than the beginning and end is due to the unavoidable effects of COVID-19.

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During this middle time period, PCU patients were displaced among different units as ICU

patients were moved into the PCU to accommodate the growing numbere of COVID-19 patients

within the facility. This led to a chaotic time in general for nursing and the focus on turing

compliance was decreased.

Adverse Events

Fortunately, there were no adverse patient outcomes reported throughout the

implementation, except complaints from patients that did not like to be turned every two hours.

One negative outcome that the DNP student had not predicted was staff members throwing away

sensors when unnecessary, such as when a patient went for MRI or simply because the sensor

became unattached. This decreased throughout the data collection time period as the DNP

educated staff on using a transparent dressing to replace the sensor instead of throwing it away

and using a new one. Lastly, an unintended negative outcome was the attitude toward the DNP

student from a few staff members for implementing the technology that focused on turning

patients every two hours, specifically at night. This was definitely not expected, but change,

especially in the work place, is very rarely well-accepted by all.

Recommendations

Due to the success of the reduction of PIs with this QI, it would be valuable to extend the

implementation of this technology to every unit within the hospital. The population at MCF

includes patients with many chronic medical conditions that are admitted to all units, therefore

providing an opportunity to improve turning compliance and ultimately reducing PI prevalence

throughout the entire hospital. Secondly, a recommendation for installing a central display in the

dialysis unit of the hospital would be beneficial. This would reduce the pause-time by at least 12

hours a week per patient, due to dialysis typically running for four hours, three days a week. This

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would not only improve the turning compliance, but continue to prevent chronically-ill patients

from developing a PI. Expanding the use of the Leaf technology throughout the entire facility

would further demonstrate that MCF is staying intune with the sophistication of technology in

healthcare and support the current Magnet status of the institution.

Another recommendation for the continued use of this technology throughout the hospital

would be to create a “super user” group of staff members who are well-edcuated on the

technology. The DNP student was the main and only resource for the technology, so whenever

the DNP student was working, trouble-shooting and assisting staff to better understand and use

the technology was very prevalent. However, the DNP was not there every day. Creating a

“super user” group would ensure that staff members have resources available in-person almost

every shift and would increase turning compliance and general understanding by staff.

Another recommendation that can be taken from this QI stems from the next step in the

DNP student’s career. As a future provider, the student has a deeper knowledge regarding the

detriment a PI can have on a patients health status, as well as overall quality of life. To focus on

prevention of HAPIs using the technology, the recommendation would be to include an order for

the application of the Leaf sensor be added to the admission orders on all patients. This order

would simply state to apply a Leaf sensor if the patient qualifies per the criteria or based on

nursing judegement. By making this a provider order, it would serve as a firm reminder to ensure

that staff thinks about using the Leaf on all patients necessary to further the benefit for patients

and the investement in the technology.

Discussion

The implementation of the Leaf Patient Monitoring System in the PCU at MCF

ultimately reduced the number of HAPIs for the 68 patients monitored over the three-month time

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period. This provides evidence that the reduction of HAPIs is indeed a nursing-sensivity quality

measure, as Florence Nightingale brilliantly declared long ago. In addition to the HAPI reduction

being a reflection of the nursing quality at MCF, it also assists in reducing the financial stress

that HAPIs can place on an institution. MCF has improved the quality of care the patients

receive, decreased the chance of reimbursement penalties by CMS, and decreased the out-of-

pocket expenses that come with HAPIs with the use of this technology. The expansion of use of

the Leaf technology would benefit the future patient population, the facility as a whole, and

reflect the leadership of the institution in healthcare innovation.

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Appendix A

Braden Scale

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Appendix B

Best Practice Framework

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Appendix C

Best-practice framework of quality improvement interventions for pressure ulcer prevention in

hospitals

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Appendix D

Review of Literature

Year Author, Title, Journal Purpose Design Pearls

2015 Black, J., (2015). Pressure

ulcer prevention and

management: a dire need for

good science. Annals of

Internal Medicine.

https://doi.org/10.7326/M15-

0190

Discuss current PI practice

from 2014 International

Clinical Practice Guidelines

and American College of

Physicians

• The 2014

international clinical

practice guideline on

pressure ulcer

prevention and

treatment includes

only 77 statements

with evidence to

support them,

whereas the

remaining 498

statements are based

on expert opinion

Editorial • ACP provides guidelines on systematic reviews

funded by AHRQ.

• the low sensitivity and specificity of pressure

ulcer risk assessment are expected because risk

can change within minutes. These varying risks

are not captured unless the risk assessment tool

is completed contemporaneously with changes in

patient condition.

• The success of multicomponent interventions in

reducing pressure ulcer incidence is believed to

be attributable to their engagement of leadership

and administration, involvement of direct care

providers, continuous education of staff, and

sustained audits and feedback

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Year Author, Title, Journal Purpose Design Sample Result

2018 Cox, J., Roche, S., &

Murphy, V. (2018).

Pressure injury risk factors

in critical care patients: a

descriptive analysis.

Advances in Skin & Wound

Care, 31(7), 328-334.

To describe the

risk factors

associated with

PI development

in a sample of

medical-surgical

intensive care

unit patients and

determine

whether these

risk factors were

congruent with

the risk factors

proposed in the

work of the

National

Pressure Ulcer

Advisory Panel

on unavoidable

PIs

Retrospective,

descriptive design

• 57 critically ill patients

admitted to the

medical-surgical

intensive care unit for

more than 24 hours and

who acquired a PI

during their admission

• immobility (n = 57

[100%]), septic shock

(n = 31 [54%]),

vasopressor use (n = 37

[65%]), head-of-bed

elevation greater than

30- (n = 53 [93%]),

sedation (n = 50

[87.7%]), and

mechanical ventilation

for more than 72 hours

(n = 46 [81%]).

• Top two diagnoses

were sepsis and

respiratory failure

Use of Braden scale for PI risk

assessment is current use, but does

not account for many other risk

factors of this population

(advanced age, prolonged ICU

admission, medical history [DM,

CV disease, hypotension],

mechanical ventilation,

vasopressor agents, decreased

mobility/activity.

While the implementation of ag-

gressive prevention strategies is

essential to reducing PI prev-

alence, it is also important to

recognize that certain clinical

conditions may result in exposure

to risk factors that go be- yond the

scope of prevention

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Year Author, Title, Journal Purpose Design Sample Result

2014

Doucette, M., Adams, S.,

Cosdon, K., & Payne, K.,

(2014). “Drive to zero”:

using wearbale technology

for pressure ulcer

prevention on a medical-

surgical unit.

To assess use of

new technology

to identify turn

adherence

Pragmatic, multi‐center, open label,

prospective,

cluster‐randomized

controlled trial

• Sixty-nine patients with

mean Braden score of

19.4 (min 13, max 23)

were monitored over 31

days. A total of 3287

hours of monitoring

data was collected.

Average monitoring

time per patient was 47

hours

• The average compliance to the

two-hour turn protocol was

88.5% (min 82%, max 99%).

There were a total of 292 turn

alerts. Twelve patients (17%)

never had a turn alert, ten of

whom had Braden scores above

18.

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Year Author, Title, Journal Purpose Design Sample Result

2019 Hodl, M., Eglseer, D., &

Lohrmann, C. (2019).

Does conducting a risk

assessment facilitate better

care for patients at risk of

pressure injuries?.

Advances in Skin & Wound

Care, 32, 365-369.

To evaluate if

the use of a

pressure injury

(PI) risk

assessment is

associated with

the more

frequent use of

international

evidence-based

guideline

interventions in

patients at risk

of PI.

Multicenter cross-

sectional

prevalence study

• 532 patients 65 years at

risk of PI or older in

Austrian hospitals

Conducting and documenting a

risk assessment led to more

recommended interventions being

performed

These findings show that

conducting and documenting a risk

assessment were positively

correlated with the more frequent

use of internationally

recommended PI prevention

measures, such as the provision of

moisture/barrier cream, use of

mobilization specific for PI,

malnutrition screening, and

floating heels/ heel suspension

devices

These findings are in line with

international guidelines, which

highly recommend that a risk

assessment be conducted within 8

hours of admission for all patients.

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Year Author, Title, Journal Purpose Design Sample Result

2019 LeBlanc, K., Woo, K.,

Bassett, K., & Botros, M.,

(2019). Professionals’

knowledge, attitudes, and

practices related to

pressure injuries in

Canada. Advances in Skin

& Wound Care, 32(5),

228-233.

To describe the

pattern of PI

prevention and

identify national

priorities and

opportunities to

address PIs.

Descriptive, cross-

sectional, online

survey

590 surveys were

completed

• Eighty-five percent of respondents

confirmed that PIs occur in their

work environments. Most of the

respondents (91%) confirmed that

they were part of a team that treats

PIs. Of the 590 participants, 90%

confirmed that they are aware of PI

prevention devices and technologies.

Between 80% and 90% attest to

using offloading devices including

prophylactic dressings to prevent

PIs, but only 20% instituted

measures to address moisture-

associated skin damage.

• It is evident that, although the

majority of respondents were aware

of PIs and related treatment

protocols, barriers still exist that

impede optimized care and

treatment.

• There are three main barriers to

effective and optimized PI care:

organizational, provider, and patient

barriers.

• PI treatment barriers include high

nurse-to-patient ratios, resource

constraints, and insufficient

integration of best practices into

organizational structures and

processes.

• Evidence-informed strategies to

promote skin health and reduce the

incidence of skin breakdown are

integral to safeguard patient safety,

quality of care, and judicious use of

healthcare resources.

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Year Author, Title, Journal Purpose Design Sample Result

2020 Li, Z., Lin, F., Thalib, L.,

& Chaboyer, W. (2020).

Global prevalence and

incidence of pressure

injuries in hospitalized

adult patients: a systematic

review and meta-analysis. International Journal of Nursing Studies, 105.

To

systematically

quantify the

prevalence and

incidence of

pressure injuries

and the hospital-

acquired

pressure injuries

rate in

hospitalized

adult patients

Systematic review

and meta-analysis

• Studies with

observational, cross-

sectional or

longitudinal designs,

reporting pressure

injury among

hospitalized adults

(≥16 years) and

published in English

• 42 were included in

the systematic review

and 39 of them were

eligible for meta-

analysis, with a total

sample of 2,579,049

patients

• Medline, PubMed,

Embase, Cochrane

Library, CINAHL and

ProQuest databases

from January 2008 to

December 2018

• study suggested that the burden

of pressure injuries remains

substantial with over one in ten

adult patients admitted to

hospitals affected

• Superficial pressure injuries,

such as Stage I and II, are most

common stages and are

preventable. Thus, healthcare

providers need to take ac- tions

in preventing superficial stages

from occurring or worsening

• highlight healthcare institutions’

focus on pressure injuries

globally and supports the need

to dedicate resources to

prevention and treatment on

pressure injuries

• The burden of pressure injury

was identified to be substantial

with the overall prevalence of

12.8% in hospitalized adult

patients

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Year Author, Title, Journal Purpose Design Sample Result

2019

Lin, F., Wu, Z., Song, B., Coyer,

F., & Chaboyer, W. (2019). The

effectiveness of multicomponent

pressure injury prevention

programs in adult intensive care

patients: a systematic review.

International Journal of Nursing

Studies, 102, 1-14.

https://doi.org/10.1016/j.ijnurstu.

2019.103483

Evaluate the

effectiveness of

pressure injury

prevention

programs in re-

ducing pressure

injury

prevalence and

incidence in

the adult

intensive care

population

Systematic

Review

Twenty-one peer

reviewed papers

Common components of

the programs included:

clarification of staff

roles, introducing new

roles, repositioning, staff

and patient education,

support surfaces use,

pressure injury risk

assessment, skin

assessment, nutrition

needs assessment,

documentation,

multidisciplinary team

involvement, and

mobilization.

• Five of the eight research

studies and one of the

quality improvement

projects reported

significant decrease in

pressure injury

prevalence, and/or

increase in compliance to

pressure in- jury

prevention protocols and

strategies.

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Year Author, Title, Journal Purpose Design Sample Result

2015 Marsden, G., Jones, K.,

Neilson, J., Avital, L.,

Collier, M., & Stansby, G.

(2015). A cost-

effectiveness analysis of

two different repositioning

strategies for the

prevention of pressure

ulcers. Journal of

Advanced Nursing.

To assess the

cost effectiveness

of two

repositioning

strategies and

inform the 2014

National Institute

for Health and

Care Excellence

clinical guideline

recommendations

on pressure ulcer

prevention.

Economic analysis

took the form of a

cost-utility model

Systematic review

of clinical data

235 patients evaluated over

5 weeks from nursing

home

Intervention 1: 4 hours in a

semi-Fowler 30° position

and 4 hours in a lateral

position 30°. The semi-

Fowler position consisted

of a 30° elevation of the

head end and the foot end

of the bed. In a lateral

position, the position, the

patient was rotated 30°,

with their back supported

with an ordinary pillow.

Intervention 2:

Repositioning was the

same as above but with 4

hours spent in the semi-

Fowler 30° position

alternating with 2 hours in

a lateral 30° position.

Patients in both groups

were lying on a visco-

elastic foam overlay

mattress

• We do not know that

intervention 1 is a cost-

effective strategy compared

with all other possible

repositioning strategies, only

that intervention 2 is not cost

effective compared with

intervention 1.

• Alternating was not cost-

effective

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Year Author, Title, Journal Purpose Design Sample Result

2011

Moore, Z., Cowman, S., &

Conroy, R.M., (2011). A

randomized controlled

clinical trial of

repositioning, using the 30

degree tilt, for the

prevention of pressure

ulcers. Journal of Clinical

Nursing, 20, 2633-2644.

Doi: 10.1111/j.1365-

2702.2011.03736.x

To compare the

incidence of

pressure ulcers

among older

persons nursed

using two

different

repositioning

regimens

Pragmatic, multi‐center, open label,

prospective,

cluster‐randomized

controlled trial

• The experimental group

(n = 99) were

repositioned three

hourly at night, using

the 30° tilt; the control

group (n = 114)

received routine

prevention (six-hourly

repositioning, using 90°

lateral rotation)

• Three patients (3%) in the

experimental group and 13

patients (11%) in the control

group developed a pressure

ulcer

• Repositioning older persons at

risk of pressure ulcers every

three hours at night, using the

30° tilt, reduces the incidence of

pressure ulcers compared with

usual care

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Year Author, Title, Journal Purpose Design Sample Result

2018

Padula, W.V., Pronovost,

P.J., Makic, M.B.F., Wald,

H.L., Moran, D., Mishra,

M.K., & Meltzer, D.O., (-

2018). Value of hospital

resoures for effective

pressure injury prevention:

a cost-effectiveness

analysis. BMJ of Quality

and Safety, 28, 132-141.

doi:10.1136/bmjqs-2017-

007505

Analyze the

cost-utility of

performing

repeated risk-

assessment for

pressure-injury

prevention in all

patients or high-

risk groups.

Cost-utility

analysis using

Markov modelling

from US societal

and healthcare

sector perspectives

within a 1-year

time horizon

• three different

pressure-injury

prevention strategies

• (a) prevention

guidelines applied to

all patients daily (ie,

‘prevention-for-all

patients’)

• (b) providing ‘risk-

stratified prevention’

only to patients below

certain categorical

Braden score

thresholds (eg,

minimal-risk,

moderate-risk, high-

risk);

• (c) standard care for all

patients in which

compliance is variable

as noted previously by

Padula and colleagues

• Analysis using EHR data maintains

that pressure-injury prevention for

all inpatients is cost- effective

• Prevention-for-all would be a cost-

effective strategy for most Western

societies since prevention-for-all

was the most costly but also the

most effective strategy.

• Additionally, it may also be true

that by applying the same care

process to all patients, the process

becomes standardized, done more

efficiently and easier to monitor

and assure improved process

reliability.

• Therefore, it makes sense for

health systems to invest in quality-

improvement infrastructure

• Targeting prevention guidelines to

patients with Braden scores of less

than 15, 13, or 10 were all found to

be domi- nant when compared with

standard care. This means that it

both saved money and yielded

higher quality-adjusted life-years

(QALYs).

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Year Author, Title, Journal Purpose Design Sample Result

2010 Peterson, M.J., Schwab,

W., Oostrom, J.H.,

Gravenstein, N., & Caruso,

L.J., (2010). Effects of

turning on skin-bed

interface pressures in

healthy adults. Journal of

Advanced Nursing, 66(7),

1566-1564. doi: 10.1111/

j.1365-2648.2010.05292.x

To study of the

effects of lateral

turning on skin-

bed interface

pressures in the

sacral,

trochanteric and

buttock regions,

and its effec-

tiveness in

unloading at-risk

tissue

Descriptive,

observational

study

• 15 healthy adults

(employees) from

a university-

affiliated hospital

• Interface pressure

profiles were

obtained in the

supine position,

followed by

lateral turning

with pillow or

wedge support

and subsequent

head-of-bed

elevation to 30°.

• Standard turning by experienced

intensive care unit nurses does not

reliably unload all areas of high

skin-bed interface pressures. These

areas remain at risk for skin

breakdown, and help to explain why

pressure ulcers occur despite the

implementation of standard

preventive measures

• Raising the head-of-bed to 30° in the

lateral position statistically sig-

nificantly increased peak interface

pressures and total area ‡32 mmHg.

Comparing areas ‡32 mmHg from

all positions, 93% of participants

had skin areas with interface

pressures ‡32 mmHg throughout all

positions (60 ± 54 cm2), termed

‘triple jeopardy areas’ meaning

supine, left-turned, right-turned. The

triple jeopardy area increased

statistically significantly with

wedges as compared to pillows

• At-risk areas were statistically larger

with wedges than with pillows at the

lateral left and elevated left positions

• No trend emerged upon analyzing

peak interface pressures as height,

weight or BMI increased. However,

for at-risk areas, an increasing trend

began to emerge as weight and BMI

increased, but not height

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Year Author, Title, Journal Purpose Design Sample Result

2018

Pickham, D., Berte, N.,

Pihulic, M., Valdez, A.,

Mayer, B., & Desai, M.,

(2018). Effect of a wearable

patient sensor on care delivery

for preventing pressure injuies

in acutely ill adults: A

pragmatic randomized clinical

trial. International Journal of

Nursing Studies, 80, 12-19.

doi:

10.1016/j.ijnurstu.2017.12.012

To evaluate

whether optimal

patient turning,

defined as

regular turn- ing

every 2 h with

at least 15 min

of tissue

decompression,

reduces HAPUs

in acutely ill

patients.

Randomized

clinical trial • 1312 total patients;

653 in control group

receiving standard

practices; 659

receiving optimal

turning practices.

• All subjects will

receive a wearable

patient sensor

• Optimal pressure ulcer

prevention is defined

as regular turning

every 2 h with at least

15 min of tissue

decompression

• 103,000 h of monitoring data.

• Treatment group with 5

HAPIs, control group with 15

HAPIs

• Turning compliance of 67% in

treatment group vs 54% in

control group

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67

Year Author, Title, Journal Purpose Design Sample Result

2020 Saindon, K. & Berlowitz,

D.R. (2020). Update on

pressure injuries: a review

of literature. Advances in

skin and wound care, 33,

403-409. doi:

10.1097/01.ASW.

0000668552.48758.1c

To provide

information

about the latest

evidence-based

practice related

to pressure

injuries

Literature Review 6 articles published in 2018

and 2019 that represent

importance of PI

prevention

• Pressure injury prevention is

cost-effective

• Nixon et al. discusses specialty

mattresses as cost-effective

strategies to prevent PIs

• References the Padula et al.

article and cost-effectiveness

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Year Author, Title, Journal Purpose Design Sample Result

2017

Schutt, S.C., Tarver, C., &

Pezzani, M., (2017). Pilot

study: Assessing the effect

of continual position

monitoring technology on

compliance with patient

turning protocols. Nurse

Open, 5(1), 21-28.

The study aim

was to evaluate

if continual

patient position

monitoring,

taking into

account self-

turns and

clinician-

assisted turns,

would increase

the percentage

of time a

patient’s

position

changed at least

every 2 hr

Inpatient, non-

randomized, pre-

/postintervention

study

• Data collected May

2013–February 2014

on a 39-bed medical

unit in a community

hospital

• 138 patients across

both phases were

included in the

analysis, representing

7,854 hr of position

data.

• The baseline phase

sample (N = 75)

consisted of a different

set of patients than did

the postintervention

phase sample (N = 63).

T test results revealed lower

baseline phase turn adherence of

39%–89% (average 64%)

compared with post-intervention

phase turn adherence of 86%–

100% (Mean 98%). The

improvement in turn protocol

adherence was statistically

significant (p < .001).

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Year Author, Title, Journal Purpose Design Sample Result

2018 Shieh, D., Berringer, C.M.,

Pantoja, R., Resureccion,

J., Rainbolt, J.M., Hokoko,

A. (2018). Dramatic

reduction in hospital-

acquired pressure injuries

using a pink paper

reminder system. Advances

in Skin & Wound Care,

31(3), 118-122.

To reduce the

number of

hospital-acquired

pressure injuries

(HAPIs) by

flagging

extremely high-

risk patients with

a pink paper

reminder system

and

implementing a

pressure injury

prevention order

set.

Quality

improvement

project

All adult patients admitted

to two different hospitals

over nearly 4 years meeting

one of two criteria:

1. A Braden score of

12 or less.

2. A Braden score

less than 18 and

any 2 of the

following: age 65

years or older,

albumin level less

than or equal to 3.0

g/dL, a preexisting

pressure injury,

and skin at risk

(Table 1). Skin at

risk was defined as

any of the

following:

moisture

dermatitis, irritant

dermatitis,

blanching skin,

skin tears, and

traumatic wounds.

• 67% reduction in quarterly

HAPI rate from a mean of 1.2

HAPIs per 1000 patient-days

(measured during the first

quarter of 2009 to the fourth

quarter of 2012) to 0.4 HAPIs

per 1000 patient-days (measured

during the first quarter of 2013

through the fourth quarter of

2016).

• In 2009, there were 138 HAPIs

over 96,429 patient-days. In

2013, the year the pink paper

program was initiated, there

were 84 HAPIs over 101,600

patient-days. In 2016, the total

number of HAPIs was 32 cases

over 123,187 patient-days.

• This system was designed to

target 10% to 15% of the

hospital population. Using only

Braden scores less than 17

would encompass a much larger

percentage of the hospital

population. It is hypothesized

that this quality im- provement

project would not have been as

successful if a ma- jority of the

hospital patients were flagged as

high risk because the nursing

staff would most likely have

become desensitized to the

warning system.

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Year Author, Title, Journal Purpose Design Sample Result

2019 Yap, T.L., Kennerly, S.M.,

& Ly. K., 2019. Pressure

injury prevention:

outcomes and challenges to

use of resident monitoring

technology in a nursing

home. Journal of Wound,

Ostomy, and Continence

Nursing, 46(3), 207-213.

To examine the

usability, user

perceptions, and

nursing

occupational

subculture

associated with

introduction

of a patient

monitoring

system to

facilitate

nursing staff

implementation

of standard care

for pressure

ulcer/injury

prevention in

the nursing

home setting.

• Forty-four residents

were monitored for 2 to

21 days

• System use significantly (P =

.0003) improved compliance

with every 2-hour repositioning

standards.

• Prior to the study, the 3-month

facility-acquired PrI prevalence

rate was 7.3% (national average:

7.4%)

• Mean repositioning compliance

during the intervention period

was significantly higher than the

baseline period (t= 4.42, P=

.0003), with significant

improvements on the 3 pm to 11

pm (P=.02) and 11 pm to 7 am

shifts (P < .0001). No new PIs

developed during the baseline or

intervention periods.

• The overall NCAT (nursing

culture assessment tool for use

in LTAC) scores, although not

statistically signi - cantly di

erent before and after

implementation, suggested the

potential of PM system for

improving teamwork and com-

munication.

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71

Year Author, Title, Journal Purpose Design Sample Result

2019 Yilmazer, T. & Bulut, H.

(2019). Evaluating the

effects of a pressure injury

prevention algorithm.

Advances in Skin & Wound

Care, 32(6), 278-284.

To evaluate the

effect of a

pressure injury

prevention

algorithm on

pressure injury

prevention.

Quality

improvement

All patients older than 18

years (prealgorithm, n =

80; postalgorithm, n = 74)

Interventions included skin

care, nutrition

management,

moisture/incontinence

management, support

surface management, and

activity management

Activity management

included: q2 turns, 30

degree turn angle, no

rotation to area of redness,

do not place on medical

device, do not place in

semi-seated position, and

support extremities

• The pressure injury incidence

was 46.10 per 1,000 patient-

days in the prealgorithm

period and 9.21 per 1,000

patient-days in the

postalgorithm period. The

decline was statistically

significant (z = 9.590, P G

.001).

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Appendix E

Leaf Healthcare Reports

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Appendix F

Leaf Patient Monitoring Sensor

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Appendix G

Leaf Central Monitor Display

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Appendix H

Approval for Leaf expansion to PCU

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Appendix I

PCU Sensor Application Criteria

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Appendix J

Application criteria “badge buddy”

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Appendix K

Communication Work Flow

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Appendix L

HAPI data collection Excel spreadsheet

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Appendix M

Turning compliance data collection Excel spreadsheet

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Appendix N

Mayo IRB exemption letter

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Appendix O

JU IRB submission approval

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Appendix P

HAPI Data

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Appendix Q

Turning Compliance Data

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Appendix R

HAPI Poisson Distribution

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Appendix S

Turning Compliance Quantile Data

100.0% maximum 95

99.5% 95

97.5% 93.875

90.0% 88

75.0% quartile 85.75

50.0% median 77.5

25.0% quartile 69

10.0% 64

2.5% 46.875

0.5% 44

0.0% minimum 44

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Appendix T

Turning Compliance Day-by-Day Data